Yesterday, the General Court confirmed that the European Commission is entitled to refuse to authorize health claims despite a positive opinion from the European Food Safety Authority (EFSA).
The German company Dextro Energy (Dextro) manufactures energy products consisting almost entirely of glucose. Its products are sold in Germany and other European countries. Dextro applied for authorizations for five health claims related to glucose and contribution to energy-yielding metabolism.
Pursuant to the authorization procedure, the European Food Safety Authority (EFSA) first renders an opinion on the authorization request. This opinion is then submitted to the European Commission, which takes a decision. In its opinion, EFSA concluded that, based on the data provided, a cause and effect relationship had been established between the consumption of glucose and contribution to energy-yielding metabolism and that the wording of the claims reflected the scientific evidence. Despite this positive opinion, however, the Commission refused to authorize the claims.
The Commission's reasoning can be summarized as follows.
Health claims must be based on generally accepted scientific evidence. While the Commission generally takes into account EFSA's opinion, in some cases a scientific risk assessment alone does not provide all relevant information on which a decision should be based and therefore other legitimate factors should also be taken into account, including the fact that health claims may not be inconsistent with generally accepted nutrition and health principles.
In the Commission's opinion, Dextro's claims convey a conflicting and confusing message to consumers, as they encourage the consumption of sugar, which authorities believe should in fact be reduced based on generally accepted scientific evidence.
Consequently, the Commission ruled that the claims do not comply with Article 3.2(a) of Regulation (EC) No 1924/2006, which provides that health claims should not be ambiguous or misleading.
In addition, the Commission ruled that even if the health claims were authorised under specific conditions for use and/or accompanied by additional statements or warnings, it would not be sufficient to alleviate the confusion caused to consumers and, consequently, the claims should not be authorised.
The General Court supported the Commission’s reasoning and ruled that while the task of EFSA is to verify whether health claims are based on scientific evidence (and whether their wording meets certain criteria), the Commission must take account of the applicable EU legislation as well as other legitimate and relevant factors, including generally accepted principles of nutrition and health and the fact that the average consumer is advised to reduce his or her sugar consumption.